Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170034
| Device | Hydrus Microstent |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | Ivantis, Inc. |
| Date Received | 2019-11-27 |
| Decision Date | 2020-01-23 |
| PMA | P170034 |
| Supplement | S004 |
| Product Code | OGO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ivantis, Inc. 38 Discovery, Suite 150 irvine, CA 92618 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170034 | | Original Filing |
| S007 |
2021-11-03 |
30-day Notice |
| S006 |
2020-12-10 |
30-day Notice |
| S005 | | |
| S004 |
2019-11-27 |
Normal 180 Day Track No User Fee |
| S003 |
2019-08-27 |
Normal 180 Day Track No User Fee |
| S002 |
2019-07-24 |
Normal 180 Day Track No User Fee |
| S001 |
2018-09-07 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices